CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan 18, 2011 -
ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA), today announced
top-line data showing that ridaforolimus, an investigational oral
mTOR inhibitor, met the primary endpoint of improved
progression-free survival (PFS) compared to placebo in the Phase 3
SUCCEED trial conducted in patients with metastatic soft-tissue or
bone sarcomas who previously had a favorable response to
chemotherapy. Merck is currently developing ridaforolimus in
multiple cancer indications under an exclusive license and
collaboration agreement with ARIAD. Complete findings from the
SUCCEED trial will be submitted for presentation at an upcoming
medical meeting this year.

Based on the full analysis of 552 PFS events in 711 patients,
determined by an independent review committee, the blinded
prospective study achieved its primary endpoint, with a
statistically significant (p=0.0001) 28 percent reduction by
ridaforolimus in the risk of progression compared to placebo
(hazard ratio=0.72). Determination of median PFS for each arm of
the trial demonstrated that ridaforolimus treatment resulted in a
statistically significant 21 percent (3.1 week) improvement in
median PFS (ridaforolimus, 17.7 weeks vs. placebo, 14.6
weeks).

Based on the full analysis of PFS determined by the
investigative sites, there also was a statistically significant
(p<0.0001) 31 percent reduction by ridaforolimus in the risk of
progression compared to placebo (hazard ratio=0.69). Ridaforolimus
treatment resulted in a statistically significant 52 percent (7.7
week) improvement in median PFS (ridaforolimus, 22.4 weeks
vs. placebo, 14.7 weeks).

The most common side effects observed in the study to date were
consistent with the known safety profile of ridaforolimus and
included stomatitis (e.g., mouth sores), fatigue, diarrhea
and thrombocytopenia.

This trial remains active, and study participants continue to be
followed to gather additional data on secondary endpoints,
including overall survival and the safety profile of ridaforolimus.
Merck currently plans to file for marketing approval of oral
ridaforolimus in 2011, subject to final collection and
analysis of all available data from the trial.

“Patients with metastatic soft-tissue and bone sarcomas
have extremely limited treatment options available to them,”
stated Harvey J. Berger, M.D., chairman and chief executive officer
of ARIAD. “These top-line data illustrate how devastating
metastatic sarcomas can be, even in patients who have responded
favorably to conventional chemotherapy. We are very pleased with
the positive outcome of the SUCCEED trial and the statistically
significant improvement in progression-free survival in those
patients treated with oral ridaforolimus.”

The SUCCEED trial is a randomized (1:1), placebo-controlled,
double-blind study of oral ridaforolimus administered at 40 mg/day
(five of seven days/week) in patients with metastatic soft-tissue
or bone sarcomas who demonstrated a favorable response to prior
conventional chemotherapy. Oral ridaforolimus was granted a Special
Protocol Assessment (SPA) by the U.S. Food and Drug Administration
for the SUCCEED trial. The European Medicines Agency has also
provided protocol advice regarding the trial design as part of its
Protocol Assistance program. More information about this trial can
be found at
http://clinicaltrials.gov/ct2/results?term=NCT00538239.

Investor Call Today at 9:00 a.m. ET

ARIAD will hold an investor webcast to discuss the top-line
results of the SUCCEED trial today, January 18, 2011 at 9:00 am ET.
The live webcast can be accessed by visiting the investor relations
section of ARIAD's website at
http://investor.ariad.com. Investors can access the call by
dialing 866-804-6928 (domestic) or 857-350-1674 (international)
five minutes prior to the start time and providing the pass code
14844206. A replay of the call will be available on the ARIAD
website approximately two hours after completion of the call and
will be archived for three weeks.

About Sarcoma

Sarcomas are a group of cancers of connective tissue of the body
for which there are currently limited treatment options. Sarcomas
can arise anywhere in the body and are divided into two main groups
– bone tumors and soft-tissue sarcomas.

About Ridaforolimus

Ridaforolimus is an investigational targeted and potent
small-molecule inhibitor of the protein mTOR, a protein that acts
as a central regulator of protein synthesis, cell proliferation,
cell cycle progression and cell survival, integrating signals from
proteins, such as PI3K, AKT and PTEN, known to be important to
malignancy.

About ARIAD

ARIAD's vision is to transform the lives of cancer patients with
breakthrough medicines. The Company's mission is to discover,
develop and commercialize small-molecule drugs to treat cancer in
patients with the greatest and most urgent unmet medical need -
aggressive cancers where current therapies are inadequate. ARIAD's
lead product candidate, ridaforolimus, is an investigational mTOR
inhibitor being developed by Merck that has successfully completed
a Phase 3 clinical trial in patients with soft-tissue and bone
sarcomas and is being studied in multiple cancer indications.
ARIAD's second internally discovered product candidate, ponatinib,
is an investigational pan-BCR-ABL inhibitor in a pivotal Phase 2
clinical trial in patients with chronic myeloid leukemia and Ph+
acute lymphoblastic leukemia. For additional information, please
visit
www.ariad.com.

This press release contains "forward-looking statements"
including, but not limited to, statements relating to top-line
clinical data for ridaforolimus in the treatment of metastatic
soft-tissue and bone sarcomas. Forward-looking statements are based
on management's expectations and are subject to certain factors,
risks and uncertainties that may cause actual results, outcome of
events, timing and performance to differ materially from those
expressed or implied by such statements. These risks and
uncertainties include, but are not limited to, results of clinical
studies of ARIAD's product candidates, timing and acceptance of
regulatory filing for drug approval, and other factors detailed in
ARIAD's public filings with the U.S. Securities and Exchange
Commission. The information contained in this press release is
believed to be current as of the date of original issue. ARIAD does
not intend to update any of the forward-looking statements after
the date of this document to conform these statements to actual
results or to changes in ARIAD's expectations, except as required
by law.

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